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NCT01666678 · ClinicalTrials.gov registry record · Phase 1
Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT01666678 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 32 participants.
The verdict
NCT01666678, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of the current trial is to evaluate the bioavailability of a single oral dose of naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or DPH HCL (2 Allergy Relief x 25 mg tablets) under fasting conditions.
Interventions
- DRUG BAY98-7111
- DRUG Naproxen Sodium (Aleve, BAYH6689)
- DRUG Diphenhydramine HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01666678
The ClinicalTrials.gov registry entry for NCT01666678 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which BAY98-7111 is the first listed.
NCT01666678 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01666678 about?
NCT01666678 is a clinical study titled "Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination". The purpose of the current trial is to evaluate the bioavailability of a single oral dose of naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or DPH HCL (2 Allergy Relief...
What is the current status of trial NCT01666678?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2012-01. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01666678?
The interventions under investigation include: BAY98-7111 (DRUG), Naproxen Sodium (Aleve, BAYH6689) (DRUG), Diphenhydramine HCl (DRUG).
Who is sponsoring clinical trial NCT01666678?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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